The FDA's promo police are back in action with the fourth untitled letter of the year—and it's a second one for Ascend Therapeutics’ estrogen therapy EstroGel. Ascend is in trouble (PDF) this time for including misleading claims in a sell sheet.
In 2015, the drugmaker got slapped in an untitled letter (PDF) for leaving out drug-risk info in a promotional Zazzle card for the same drug.
The new letter calls out Ascend's sell sheet for claiming EstroGel has the lowest effective dose of estrogen compared with similar products—which is untrue, according to the agency. Other FDA-approved products do sport lower doses.
The marketing material cites two studies OPDP blows up as "not sufficient to support claims suggesting that the dose of estradiol in EstroGel has been proven to be the lowest effective dose of estrogen for the treatment of symptomatic postmenopausal women," adding that the EstroGel studies weren't sufficient to prove claims that rival low-dose estrogen products are not effective.
John Driscoll, an independent regulatory affairs consultant, noted in a Twitter post, “Most obvious point from today’s #OPDP letter: Don’t suggest that an FDA-approved competitor product is not safe and effective.”
Ascend is a subsidiary of Besins Healthcare, and EstroGel is its only product listed on the Ascend website. The OPDP asked that Ascend respond to its letter by Aug. 30 with a plan for discontinuing the sell sheet. Ascend did not respond to FiercePharma requests for comment.
Ascend’s letter is the fourth for the year from OPDP, which in the past several years has slowed its output of cautionary letters to pharma companies. The agency only sent five last year, down from 11 in 2016 and nine in 2015.
Ascend wasn’t the only wrist slapped this week by the FDA. On Tuesday, the agency issued warning letters to four online networks, which run a total of 21 websites, that illegally market unapproved and misbranded versions of opioid medications. The FDA effort follows a similar smackdown earlier this summer against nine online pharmacies operating 53 websites selling suspect opioids.
FDA Commissioner Scott Gottlieb said today in a statement that the FDA won’t let up.
“The FDA remains resolute in our promise to continue cracking down on these networks to protect the public health. We have more operations underway, and additional actions planned. We are also working closely with legitimate internet stakeholders, including leading social media sites, in these public health efforts,” he said.